Legislative of medical device at international markets
Learning objective
In this session the most important regulations in critical markets will be introduced. Besides it, the participants should learn how to follow diverse global regulations.
Types of legislative
Law
The most familiar law is Federal Food, Drug, and Cosmetic Act (FD&C Act) in US and EU Medical Device Regulation (MDR). So they are legal binding for all stakeholders in healthcare.
Like in many markets the law in healthcare is combined with drug, medical device and IVD. So it is quite challenging that the exact part of medical device or IVD can be read out. In the United States Code (U.S.C.) at Title 21 food and drugs, Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT and Subchapter V: Drugs and Devices it is stipulated about drugs and devices. In EU MDR it is clearly divided to MDR for medical device and IVDR for in vitro diagnostic.
The language of law is often juridical, compact and abstract. It is recommended to follow supporting guidance to know the details of law in specific topic.
With the evolution of law of medical device there are amendments. It is tough to just study only amendment text at law without context of the whole law. Among amendment it is worthy to focus on the change but keep an overview of consolidated law.
Regulation
In many countries the highest regulation of medical device is not binding law and others named. Currently in China they have state council order 739 which will be replaced by a medical device act as historic first law in the hugest market in the world.
The regulation can be understood also as legislative, regulatory requirement et cetera.
It is diverse follow global regulation of medical device at website of authority. The Canadian regulations of medical device are shown in one page as in health Canada[1]. The MDCG guidance in EU is nicely published in categorised topics[2].
Or at website[3] in Taiwan food and drug administration by giving keyword regulation, all are listed in chronological order.
The regulation in general is explanatory guideline for law or act of medical device. It is intelligent to find general requirement or texts at law and to match details in belonging regulations.
Standards
Standard: Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.
The state of the art standards are International Organization for Standardization IEC and International Electrotechnical Commission (IEC) ISO.
International Organization for Standardization (ISO)
Role: Develops international standards for medical devices, such as ISO 13485 (quality management systems) and ISO 14971 (risk management).
Guidance: Standards are widely adopted by regulators and industry.
International Electrotechnical Commission (IEC)
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Role: Develops standards for electrical and electronic medical devices.
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Guidance: Key standards include IEC 60601 (safety and performance of medical electrical equipment).
Unfortunately, each country implements these international standards with its own transformations and modifications. The typical country-specific standards include:
Japan: Utilizes the JIS (Japanese Industrial Standards)
China: Implements GB (Guobiao) standards and YY standards, particularly for medical devices
Germany: Often follows the DIN (Deutsches Institut für Normung) standards
Another challenge arises due to language and local regulatory focus: country-specific standards are formulated and emphasized differently. When comparing these with international standards, you may encounter the following designations in various publications:
IDT (Identical): The local standard is identical to the international version.
MOD (Modified): The local standard has been modified to suit national conditions or regulatory priorities.
NEQ (Not Equivalent): The local standard is not considered equivalent to the international standard, often due to differences in regulatory scope or technical requirements.
Understanding these differences is critical for regulatory affairs professionals. When preparing technical documentation or engaging in market approval processes, it is essential to recognize:
The need for localized interpretations: Even if a device meets ISO or IEC standards, additional testing or documentation may be required to satisfy local standards (e.g., GB/YY in China, JIS in Japan, or DIN in Germany).
Language barriers and terminology differences: Translations and local interpretations may affect the formulation and focus of the standard, which in turn influences how products are evaluated and certified.
Strategic compliance: To ensure smooth market entry, manufacturers must not only comply with international standards but also tailor their documentation to reflect the specific requirements and modifications mandated by each country.
By understanding both the international and localized standards, manufacturers can streamline their regulatory submissions and ensure that their products meet the necessary criteria in every target market. This dual focus on global and local compliance is crucial in the highly regulated field of medical devices.
How to study international standards with other language? Either through translation or using online translation tool it is worthy to find information as follow:
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Validity date, transition time
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Replacing standard
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Applied product
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Revision history
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Cited international standard
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How and what to follow regulations
The international regulations of medical device are evolving rapidly. It is worthy to get fresh information from local distributor or subsidiary or consulting. Otherwise there are valuable resources at website of authority and newsletter at consulting. Do not miss recurring training, webinar and workshops.
From international view there are International Medical Device Regulators Forum (IMDRF) and World Health Organization (WHO).
Under MDR there are many institutions issuing guidance as Team NB, Medical Device Coordination Group.
In Asia there is Asian Harmonization Working Party (AHWP) and Association of Southeast Asian Nations (ASEAN). Round Russia, Kyrgyzstan, Kazakhstan, Belarus and Armenia there is EURASIAN.
Not all regulations can be monitored and assessed. Besides product specific regulation at international markets these topics should be taken into account and traced:
Law
Registration regulation (technical documentation and review)
Classification
Labelling (including UDI)
Quality management system (including inspection)
Post market surveillance
Clinical evidence
How to maintain regulations and standards
It is easy to back up chronologically the regulation from different resources. After monitoring the new regulation, the responding department at manufacturer of medical device should have a gap analysis with existing process and eventually make an action if the gap was found. To better look after the regulation, it is always nice to group regulations in topics and have an overview for the whole company.
Do not forget to put desolate regulations in archive with rising market specific regulations. A common table of content of regulation in one market is assigned to country responsible RA to maintain.
[3] https://www.fda.gov.tw/ENG/law.aspx?cid=5063&cr=350120300&r=02
Test and case study
These contents are only for enrolled student.